Descripción del Trabajo
Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing.
ESSENTIAL DUTIES AND RESPONSIBILITIES
• Understand & follow site safety policies and procedures related to work activities performed in area of responsibility and actively promote a safety culture.
• Support attainment of key business metrics through the provision of Quality Engineering support for value stream processes.
• Study the effectiveness of inspection activities.
• Design means for measuring accuracy and documenting of inspection work.
• Recommend and evaluate inspection gauges and test equipment.
• Perform root cause analysis for product defects and quality processes.
• Provide day-to-day Quality Engineering support for Quality Systems and Manufacturing departments.
• Implement process control systems.
• Provide Quality and Manufacturing technical support for component, product and process validations.
• Provide Quality and Manufacturing technical support for new product transfer.
• Coordinate training of manufacturing associates as applicable.
• Establish and maintain appropriate documentation as required for Quality Systems activities.
• Quality team member participating in New Product Introduction process.
• Participate in Customer Complaint investigation process.
• Support Nonconformance & CAPA investigations and actions to determine root cause and corrective actions as needed.
• Support day to day operations through attendance at CAC, TIC, MIC and QIC meetings and the timely closure of assigned actions.
• Provide support to the team in Root Cause Analysis of supply and quality issues as they arise through tools such as 8D, A3, and Six Sigma.
• Project Management - provide timely and accurate reporting on project activities ensuring projects are delivered to agreed timelines.
• Perform Statistical Analysis, including: ANOVA, DOE, Weibull, GR&R, Capability, FMEA, and TMVs as required.
• Participate in validation process for manufacturing processes, gauges, inspection equipment, software and computerized systems as required.
• Prepare written protocols as necessary.
• Provide leadership to QS organization through continuous improvement & cost reduction projects.
• Interface with manufacturing area and other support groups to ensure department objectives are met.
• Follow all company safety policies and other safety precautions within the work area.
• Promote safety to all associates and complete required safety training.
· Participate and support with Internal / External Quality / Regulatory Audit process.
· Adhere to the site’s EHS Code of Conduct.
· Evaluate and/or design sampling plans and process control plans for lot acceptance and control processes.
Other responsibilities may be assigned and not all responsibilities listed may be assigned.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
• Job is not responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
• Report to Site Quality Engineering Manager or Quality Engineering Leader
JOB QUALIFICATIONS & KNOWLEDGE REQUIREMENTS
• Excellent written and oral skills and the ability to organize and follow up on multiple, concurrent priorities.
• Able to make solid decisions that will effectively support the business and company policies.
• Able to work in a self-paced environment and provide leadership to team as appropriate.
• Team player.
• Project Management skills.
• Able to understand application of regulatory requirements to the business.
• Able to analyze and develop quality methods. Responsible for writing clear and concise protocols, study reports, and procedures.
• This position requires consistent involvement with and knowledge of changes in regulations and standards.
• Aptitude to respond to shifting priorities through appropriate realignment of required tasks. Personal computers Proficiency required.
• Skilled in use of PC based systems including, but not limited to statistical tools, inventory management, complaints handling, non-conforming product systems and data base management, and document change management systems.
Bachelor's degree required and two years related experience; or equivalent combination of education and experience.